Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Reported: March 26, 2025 Initiated: February 20, 2025 #Z-1371-2025
Product Description
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Reason for Recall
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Details
- Recalling Firm
- Microbiologics Inc
- Units Affected
- 6 units
- Distribution
- US Nationwide distribution in the states of TX. UK.
- Location
- Saint Cloud, MN
Frequently Asked Questions
What product was recalled? ▼
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N. Recalled by Microbiologics Inc. Units affected: 6 units.
Why was this product recalled? ▼
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1371-2025.
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